Diamyd Medical has aligned with the US Food and Drug Administration to advance the primary efficacy readout of its pivotal Phase 3 DIAGNODE-3 trial in type 1 diabetes by nine months, moving the main analysis point from 24 months to 15 months. The change follows FDA guidance and is expected to accelerate the availability of key trial results supporting the company’s precision medicine approach.
The DIAGNODE-3 study is a randomized, double-blind, placebo-controlled, registrational Phase 3 trial evaluating Diamyd® in approximately 300 genetically defined individuals with Stage 3 type 1 diabetes. The therapy is designed to preserve endogenous insulin production by targeting the underlying autoimmune process in a selected patient population.
The co-primary efficacy endpoints are C-peptide area under the curve, which reflects the body’s own insulin secretion, and HbA1c, a measure of long-term blood glucose control. Following the updated trial design, the primary efficacy analysis will be conducted at 15 months, while the originally planned 24-month assessment will remain as a secondary endpoint to evaluate durability of effect.
The previously announced interim efficacy readout, based on around 170 participants who have completed 15 months of follow-up, remains on track for the end of March 2026. This interim analysis may support a potential accelerated Biologics License Application pathway in line with FDA guidance.
The DIAGNODE-3 trial has received Fast Track and Orphan Drug designations from the FDA. The agency has also confirmed C-peptide as an acceptable surrogate endpoint that could support accelerated approval in the United States, provided clinical benefit is demonstrated.
